[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600914":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":36,"locations":44,"responsibleParty":71,"collaborators":73,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":10,"enrollmentInfo":96,"targetDuration":10,"studyType":99,"phases":10,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1",null,"Group 1 includes adults over 60 years old diagnosed with late-onset communicating hydrocephalus, characterised by gait apraxia, with or without cognitive impairment and urinary dysfunction. Eligibility is confirmed through clinical imaging showing an Evan's index \\>0.3 and an iNPH Radscale score \\>4. Individuals with recent severe head trauma, high-pressure hydrocephalus, or alternative causes for similar symptoms are excluded. This criteria for group 1 ensures a distinct group for studying the late-onset, communicating form of the condition.",[13,14,15],"Procedure: Ventriculoperitoneal Shunt (VP)","Procedure: Brain and Skin Biopsy","Diagnostic Test: MRI Brain",{"label":17,"type":10,"description":18,"interventionNames":10},"Group 2","Group 2 will include 30 adult patients with asymptomatic chronic hydrocephalus, non-hydrocephalus dementia and healthy controls.",[20,27,31],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Ventriculoperitoneal Shunt (VP)","VP Shunt surgery involves surgical insertion of a catheter (tube) to divert brain fluid from the cerebral ventricles to the abdominal peritoneum. This will be performed in Group 1 patients as clinically indicated.",[9],[26],"VP Shunt",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Brain and Skin Biopsy","Brain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"DIAGNOSTIC_TEST","MRI Brain","MRI brain with diffusion imagining will be performed before and after shunt surgery.",[9],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Chris Carswell","CONTACT","+44 20311 1234","NPH@imperial.ac.uk",{"name":43,"role":39,"phone":40,"phoneExt":10,"email":41},"Harvey G Burns",[45],{"facility":46,"status":47,"city":48,"state":10,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Imperial College Healthcare NHS Trust","RECRUITING","London","W6 8RF","United Kingdom","UK",{"type":53,"coordinates":54},"Point",[55,56],-0.12574,51.50853,{"lat":56,"lon":55},[59,61,62,64,67,69],{"name":60,"role":39,"phone":40,"phoneExt":10,"email":41},"Chris Carswell, PHD, FRCP",{"name":43,"role":39,"phone":40,"phoneExt":10,"email":41},{"name":60,"role":63,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":10,"phoneExt":10,"email":10},"Harvey Burns, BSc, MRes","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":10,"phoneExt":10,"email":10},"Josephine Schena, BSc, MSc",{"name":70,"role":66,"phone":10,"phoneExt":10,"email":10},"Alex Hayes, MBBS",{"type":72,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[74,77,79,81,83],{"name":75,"class":76},"Medical Research Council","OTHER_GOV",{"name":78,"class":6},"Michael J. Fox Foundation for Parkinson's Research",{"name":80,"class":6},"University College, London",{"name":82,"class":6},"University of Edinburgh",{"name":84,"class":6},"King's College London","100600914","white-matter-distortion-and-dementia-biomarkers-in-normal-pressure-hydrocephalus-nph-100600914",false,"NCT07103681","White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)","Observational Study to Investigate the Effect of White Matter Tract Distortion and Neurodegenerative Biomarkers on Shunt-responsiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)","OWN-NPH","Group 1 (communicating hydrocephalus):\n\nInclusion Criteria:\n\n* Adult patients \\>60\n* With gait apraxia\n* With or without cognitive impairment\n* Urinary dysfunction\n* Communicating Hydrocephalus\n\nExclusion Criteria:\n\n* Asymptomatic hydrocephalus\n* High pressure-hydrocephalus\n* Serious head injury within 5 years of presentation or a clear secondary cause (e.g. brain infection)\n* History of childhood gait disturbance\n* Clear alternative explanation for symptoms (e.g. Parkinson's disease with limb rigidity, peripheral neuropathy with sensory ataxia, cervical myelopathy).\n* Too frail for shunt surgery\n* Medically unstable (e.g. active angina, respiratory disease, recurrent delirium, active epilepsy).\n* Unable to tolerate MRI brain imaging\n* Unable to have a lumbar puncture\n* Immobile\n* Unable to attend the hospital for study visits\n\nGroup 2 (asymptomatic and non-hydrocepahlus dementia and healthy controls):\n\nInclusion Criteria (Any of the following):\n\n* Healthy Carers\n* Members of the Public\n* Staff of Imperial College\u002FICHT\n* Non-NPH Dementias (including Alzheimer's disease or vascular dementia)\n* Asymptomatic Hydrocephalus\n\nExclusion Criteria:\n\n\\- Unable to attend the hospital for study visits",true,"ALL","60 Years",{"count":97,"type":98},100,"ESTIMATED","OBSERVATIONAL","Idiopathic Normal Pressure Hydrocephalus (iNPH) is a progressive condition of the elderly that results in severe disability. iNPH can dramatically respond to Cerebral spinal fluid(CSF)-shunting where excess ventricular fluid is diverted from the brain. Not all patients with iNPH respond to CSF-shunting however. The reasons for this are uncertain.\n\nAim 1: To understand if specific nerve pathways (white matter tracts) that are near ventricles are damaged in patients that respond to shunting as opposed to those that do not.\n\nAim 2: Can we explain shunt non-responsiveness by screening for dementia like illnesses (neurodegeneration) using a large array of methods.\n\nAim 3: To understand whether wearable activity and bed sleep monitors are palatable in a NPH population and to understand if these metrics relate to quality of life.\n\nAim 4: To see whether self-administered digital cognitive assessments can measure improvements pre and post surgery.",[102],"Normal Pressure Hydrocephalus",[104,105,106,107,108,109,110,111,112,113,114],"hydrocephalus","activity monitors","gait impairment","shunt surgery","protokinetic","normal pressure hydrocephalus","shunt-responsiveness","white matter tractography","diffusion tensor imaging","neurodegenerative","NPH","2026-03-24",{"date":117,"type":118},"2026-03-27","ACTUAL",{"date":120,"type":118},"2025-03-25",{"date":122,"type":98},"2029-02",{"name":5,"class":6},1]